This frightens me a little bit. I'm not too paranoid, and thankfully my doctor (a D.O.) tried other methods before resorting to a prescription (if possible); but I still don't like the prospect, and plenty of people have been affected by this.

NEW YORK (CNN) -- Every year, doctors write approximately 65 million prescriptions for drugs not yet approved by the U.S. Food and Drug Administration, the federal agency that regulates prescription drugs.

These drugs, some of which the FDA admits could be dangerous, slip through a "black hole" in the drug approval system, according to one U.S. congressman.

"There's a regulatory black hole that makes it possible for the pharmaceutical companies to get these drugs to the stores that sell them without the FDA being able to monitor it," said Rep. Ed Markey, a Democrat from Massachusetts.

When a pharmaceutical company submits a new drug for approval, the FDA gives it a 10-digit number called a National Drug Code. The FDA provides the number before the drug is approved in order to track it through the approval process. But pharmacies use this same number as an order number that works whether or not the drug is FDA-approved.

Many doctors and pharmacists seem unaware of this wrinkle in the approval process.

"I think most doctors, maybe all doctors, assume that if a medication is on the market, it has been approved by the FDA, it must be safe and effective," American Medical Association President Ron Davis said.

Pharmacists would appear to be no better informed about the status of their drugs. A recent survey showed more than nine out of 10 retail pharmacists didn't know they could be dispensing drugs not yet approved by the FDA.

Though the FDA has known about this problem for more than four decades, it has only recently started cracking down on the practice. FDA officials said they are issuing more warnings and even pulling some drugs off the market.

Last year, for example, the FDA ordered firms to stop marketing unapproved medicines containing quinine. While approved for use against malaria, a life-threatening illness, quinine was never approved for its other common usage -- treatment of leg cramps. The drug has been linked to 665 reports of "adverse events," including 93 deaths, according to the FDA.

"It's not that simple to just sweep all these drugs off the market," said Deborah Autor, director of compliance at the FDA. "Some of these products -- not the majority -- but some of these products are medically necessary."

Jacque Gibson White said her daughter was killed by an unapproved drug more than 20 years ago. She can't believe any unapproved drugs are still on the market.

"I did not realize there are still drugs out there that weren't being monitored or approved," she said. "I still to this day do not understand how they get out there."

In 1984, White had her first and only baby, Rachel Ann. Although she was born 14 weeks early, doctors told White her daughter had an 85 percent chance of survival. But less than a month later, Rachel Anne died from what doctors said was kidney and heart failure.

White lived with the guilt of losing a child early. "I thought it was my fault," she said.

Eleven years later, a lawyer told White her daughter may have been killed by a drug called E-Ferol, which was used on her daughter. Given intravenously, E-Ferol was used to correct or prevent blindness in premature babies. So White joined one of the more than 130 lawsuits the manufacturer wound up settling.

The FDA won't say how many people have been killed or injured by unapproved drugs or even which unapproved drugs are the worst culprits. But FDA officials said some unapproved drugs that are still available could pose risks.

"There may be some, and we are working very hard to target those as quickly as we can," Autor said.

Muhammad Malik, head of two pharmaceutical companies in upstate New York, has felt the FDA's sting. He had to stop selling seven drugs to major pharmacies after the FDA took him to court.

Technically, it is illegal for manufacturers like Malik to sell unapproved drugs, but some manufacturers took the FDA's lack of enforcement as a sign of tacit approval of the practice.

Malik said he believes concerns about unapproved drugs are overblown. He thinks the FDA's testing procedures are too expensive and cumbersome for small companies like his. And despite the lack of FDA approval, Malik said he's not ashamed of his drugs and believes some of them should be brought back to market.

"I'm a man of integrity," he said. "And I'm morally obligated to give you a product that is good."

Despite knowing which drugs haven't been approved, the FDA refuses to release a full list to the public. Some common unapproved drugs include phenobarbital, an anti-convulsant, and chloral-hydrate, a sedative.

Markey said the FDA should do more to keep the public informed.

"In a modern era, in an Internet era, it makes no sense that a list cannot be put together to determine whether or not a drug has been approved by the FDA," he said.

Logged

"There is a cult of ignorance in the United States, and there always has been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that “my ignorance is just as good as your knowledge."" Isaac Asimov

Without getting overly political, this is an inherent problem with people (including doctors) trusting in the omniscience of government. The "if it's available, it must be safe" mentality is understandable, but it's extremely dangerous.

Without getting overly political, this is an inherent problem with people (including doctors) trusting in the omniscience of government. The "if it's available, it must be safe" mentality is understandable, but it's extremely dangerous.

Google "leading cause of acute liver failure" for an example.

I don't know if anyone believes that statement in its most simplistic form... There are side-effects to every single drug on the market. But it is reasonable for a Doctor to think that any drug available to them through the Pharmacy department of a drug store has cleared the FDA's red tape already... Technically, the drug makers are breaking the law by distributing their products before approval comes. Part of what's scary is that the distributors (i.e. Pharmacies) - are not voluntarily policing these kinds of things.

Logged

"There is a cult of ignorance in the United States, and there always has been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that “my ignorance is just as good as your knowledge."" Isaac Asimov

The FDA has amongst the most stringent requirements for drug approval in the world, it is likely for a drug to become available in the majority of the western world before available to the United States. It would seem that some of the statements in this piece imply an understanding of this problem, and the non-enforcement as a loophole to allow necessary drugs onto the market before the bureaucrats can approve them.:

"It's not that simple to just sweep all these drugs off the market," said Deborah Autor, director of compliance at the FDA. "Some of these products -- not the majority -- but some of these products are medically necessary."

It seems like the only want to determine which unapproved medications are truly dangerous and target them. Ultimately the whole system needs to be reformed, standards relaxed, and the means for small companies to get drugs to the market improved...but until then this loophole is a medical necessity.

"It's not that simple to just sweep all these drugs off the market," said Deborah Autor, director of compliance at the FDA. "Some of these products -- not the majority -- but some of these products are medically necessary."

It seems like the only want to determine which unapproved medications are truly dangerous and target them. Ultimately the whole system needs to be reformed, standards relaxed, and the means for small companies to get drugs to the market improved...but until then this loophole is a medical necessity.

If they are medically necessary, then there should be (or if there already is one, then they should improve it) a way to expedite the consideration of these medicines; a small panel could perform the task of determining which drugs should go into this category... But a "medical necessity?" No drug is a necessity insofar as humanity has existed without it for quite a long time. While I sympathize with those who can be saved very quickly by up-and-coming drugs, they can either wait a little longer for the approval process, or they can enter into the medical studies (experimental phase of the drugs) that don't require full FDA approval.

Logged

"There is a cult of ignorance in the United States, and there always has been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that “my ignorance is just as good as your knowledge."" Isaac Asimov

While I sympathize with those who can be saved very quickly by up-and-coming drugs, they can either wait a little longer for the approval process, or they can enter into the medical studies (experimental phase of the drugs) that don't require full FDA approval.

But the whole issue is that some patients can't wait.

If you need a treatment now, you can't wait for some advisory committee in Washington to consider your case at its next meeting. It isn't easy to get into a clinical trial, and even then, you might not be able to get the dosage level necessary to actually help (efficacy trials vs safety trials). I will actually agree with GiC here that "loopholes" like this are inevitable until there is a complete overhaul and streamlining of the process.

It isn't easy to get into a clinical trial, and even then, you might not be able to get the dosage level necessary to actually help (efficacy trials vs safety trials).

And most clinical trials are double blind studies, which means that half of the people on the trial are receiving a placebo as a control group. I was on the clinical trials for nicotine patches 20 years ago, and I knew I had the placebo patches because half the group was calm and said their patches were itchy, and I wasn't in that half of the group! We had to attend weekly support group sessions, and in one session we talked about changing our habits associated with smoking. The group facilitator suggested that we fill the ashtrays in our car with raisins, and because I was so on edge from nicotine withdrawal, I misheard him and thought he said "razors" so I stood up to complain about this barbaric suggestion for "aversion therapy"!

Logged

If you're living a happy life as a Christian, you're doing something wrong.

If you need a treatment now, you can't wait for some advisory committee in Washington to consider your case at its next meeting. It isn't easy to get into a clinical trial, and even then, you might not be able to get the dosage level necessary to actually help (efficacy trials vs safety trials). I will actually agree with GiC here that "loopholes" like this are inevitable until there is a complete overhaul and streamlining of the process.

Secondly, how many people actually find themselves in a position where a non-approved drug (that is in the stages of the approval process) is the only option, and is needed right away? I'd love to hear some hard evidence to this point. These cases tend to be brought up as anecdotal evidence, but I don't think they reflect a significant percentage of the critical-need population.

One life is valuable - and if it can be saved by a drug (approved or not) I think they have the right to that opportunity, but the reason why they have this intricate approval process is to prevent dangerous drugs from entering the marketplace. When they're able to be distributed before approval, the drug companies are circumventing that (for their own de$ire$).

Logged

"There is a cult of ignorance in the United States, and there always has been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that “my ignorance is just as good as your knowledge."" Isaac Asimov

I noticed you said you go to a DO. I'm glad some DO's still practice osteopathy regardless of the monopoly of the pharmaceutical economy as the norm of health for patients. If only insurance companies can extend their plans for osteopathic manipulative treatment (I go to a DO school ).

Logged

Vain existence can never exist, for "unless the LORD builds the house, the builders labor in vain." (Psalm 127)

If the faith is unchanged and rock solid, then the gates of Hades never prevailed in the end.

I noticed you said you go to a DO. I'm glad some DO's still practice osteopathy regardless of the monopoly of the pharmaceutical economy as the norm of health for patients. If only insurance companies can extend their plans for osteopathic manipulative treatment (I go to a DO school ).

I've always been happy with my DO, and two of my friends that went on to med-school went to LECOM to become DO's (and another went to the same school for Pharm). One of the big factors has always been the "hands-on" approach (bad pun, I know) and the reluctance to prescribe unless absolutely necessary.

« Last Edit: September 27, 2007, 11:40:05 AM by cleveland »

Logged

"There is a cult of ignorance in the United States, and there always has been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that “my ignorance is just as good as your knowledge."" Isaac Asimov